Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-03-03 @ 6:15 AM
Study NCT ID:
NCT00984633
Status:
COMPLETED
Last Update Posted:
2015-05-12
First Post:
2009-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 (Study P05976)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}, {'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-11', 'studyFirstSubmitDate': '2009-09-24', 'studyFirstSubmitQcDate': '2009-09-24', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical duration of 2 doses of Org 9426 in maintenance of muscle relaxation', 'timeFrame': 'Time from intubating dose to bolus maintenance dose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neuromuscular Blocking Agents'], 'conditions': ['Muscle Relaxation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, pharmacokinetics, and safety of Org 9426 in maintenance of muscle relaxation in adult subjects undergoing general elective surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects at least 20 but under 65 years of age.\n* Subjects of asa class 1, 2 or 3 for general elective surgery.\n* Subjects who are not considered to be pregnant.\n* Subjects scheduled for elective surgery under sevoflurane or propofol anesthesia, with anticipated duration of surgery of about 1.5-3 hours.\n* Subjects with normal laboratory values for serum electrolytes (Na+, K+, Cl-), BUN, creatinine, total bilirubin, ALP, ALAT and ASAT as judged by the investigator or the sub-investigator.\n* Subjects who received an explanation of the trial and agreed informed consent in writing to participate in the trial in advance.\n\nExclusion Criteria:\n\n* Subjects with renal dysfunction as a complication or in the history.\n* Subjects with serum creatinine level greater than 1.6 mg/dL.\n* Subjects with severe hepatic dysfunction as a complication or in the history.\n* Subjects with known significant metabolic or neuromuscular disorders.\n* Subjects with showing dyspnea, airway obstruction or bronchial asthma.\n* Subjects with a history of hypersensitivity to pancuronium bromide, vecuronium bromide or bromine.\n* Subjects with atopic diseases.\n* Subjects who have developed any systemic allergic symptoms.\n* Subjects receiving antihistamines and antiallergic agents for 1 month or more.\n* Subjects receiving any of the following drugs known to affect on the action of neuromuscular blocking agents on surgery day: calcium antagonists; anticonvulsants; aminoglycoside antibiotics; polypeptide antibiotics; or metronidazole.\n* Subjects under hypothermic anesthesia.\n* Subjects who participated as research subjects in another trial within the last 6 months or is now participating in other trials.\n* Other subjects judged to be ineligible as subjects in this trial by the discretion of the investigator or the sub-investigator.'}, 'identificationModule': {'nctId': 'NCT00984633', 'briefTitle': 'Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 (Study P05976)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 Following a Single Intubating Dose in Adult Subjects Undergoing Operation Under Sevoflurane or Propofol Anesthesia', 'orgStudyIdInfo': {'id': 'P05976'}, 'secondaryIdInfos': [{'id': '71102'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.6 mg/kg intubation dose + sevoflurane', 'interventionNames': ['Drug: Rocuronium bromide (Org 9426)', 'Drug: Sevoflurane']}, {'type': 'EXPERIMENTAL', 'label': '0.9 mg/kg intubation dose + sevoflurane', 'interventionNames': ['Drug: Rocuronium bromide (Org 9426)', 'Drug: Sevoflurane']}, {'type': 'EXPERIMENTAL', 'label': '0.6 mg/kg intubation dose + propofol', 'interventionNames': ['Drug: Rocuronium bromide (Org 9426)', 'Drug: Propofol']}, {'type': 'EXPERIMENTAL', 'label': '0.9 mg/kg intubation dose + propofol', 'interventionNames': ['Drug: Rocuronium bromide (Org 9426)', 'Drug: Propofol']}], 'interventions': [{'name': 'Rocuronium bromide (Org 9426)', 'type': 'DRUG', 'otherNames': ['SCH 900085'], 'description': '0.6 mg/kg injection intubation dose', 'armGroupLabels': ['0.6 mg/kg intubation dose + propofol', '0.6 mg/kg intubation dose + sevoflurane']}, {'name': 'Rocuronium bromide (Org 9426)', 'type': 'DRUG', 'otherNames': ['SCH 900085'], 'description': '0.9 mg/kg injection intubation dose', 'armGroupLabels': ['0.9 mg/kg intubation dose + propofol', '0.9 mg/kg intubation dose + sevoflurane']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Sevofrane'], 'description': '0.5-2.0% intravenous maintenance anesthesia', 'armGroupLabels': ['0.6 mg/kg intubation dose + sevoflurane', '0.9 mg/kg intubation dose + sevoflurane']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Diprivan'], 'description': '4-10 mg/kg/hr maintenance anesthesia', 'armGroupLabels': ['0.6 mg/kg intubation dose + propofol', '0.9 mg/kg intubation dose + propofol']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}